Total bilirubin =< 1.5 x upper limit of normal (ULN) (except in subjects with Gilbert syndrome who must have a total bilirubin < 3.0 x ULN)
Total bilirubin =< 1.5 x upper limit of normal (ULN) in absence of Gilbert disease (total bilirubin =< 3 x ULN with Gilbert); also, if hyperbilirubinemia is clearly attributed to liver metastases total bilirubin =< 3 x ULN is permitted
Total bilirubin =< 1.5 x upper limit of normal (ULN) except in the case of Gilbert disease
Total bilirubin =< 1.5 x upper limit of normal (ULN); unless patient has Gilbert disease
Total bilirubin < 1.5 x upper limit of normal (ULN) (or < 3 x ULN for subjects with Gilbert's syndrome)
Total bilirubin =< 1.5 x upper limit of normal (ULN) or 3 x ULN for Gilbert's disease
Bilirubin ? 1.5 times upper limit of normal (x ULN); if liver metastases are present, then ? 2 x ULN is allowed. Criteria does not apply to subjects with Gilbert's syndrome diagnosed as per institutional guidelines.
Total bilirubin at most1.5 x the upper limit of the normal range (ULN), except Gilbert's disease
Total bilirubin must be less than or equal to 1.5 x ULN (upper limit of normal) for the lab unless the patient has a bilirubin elevation greater than 1.5 x ULN to 3 x ULN due to Gilbert's disease or similar syndrome involving slow conjugation of bilirubin; and
Total or direct bilirubin ? 1.5 times upper limit of normal (x ULN); does not apply to subjects with Gilbert's syndrome diagnosed as per institutional guidelines.
Total bilirubin ?1.5 × the upper limit of normal (ULN) (subjects with Gilbert's Syndrome are allowed if direct bilirubin is within normal limits);
Serum bilirubin =< 1.5 × upper limit of normal (ULN); bilirubin =< 3 x ULN is permitted in individuals with documented liver involvement by lymphoma or if due to known Gilbert syndrome
Total bilirubin =< 1.5 x institutional upper limit of normal (ULN) or within 3 x the ULN for patients with Gilbert disease
Total bilirubin ?1.5 times the upper limit of normal (ULN) except for unconjugated hyperbilirubinemia of Gilbert's syndrome;
Total serum bilirubin =< 1.5 x upper limit of normal (ULN) OR if hepatic involvement by lymphoma: =< 3 x ULN for Gilbert's disease or documented hepatic involvement by lymphoma
Total bilirubin ? 1.5 x upper limit of institutional normal (ULN), unless due to Gilbert's syndrome
Total bilirubin =< 1.5 X upper limit of normal (ULN), with exception of patients with Gilbert syndrome
Total or direct bilirubin ? 2 times upper limit of normal (x ULN); does not apply to subjects with Gilbert's syndrome diagnosed as per institutional guidelines.
Total bilirubin ?2.0 x the upper limit of normal or <3.0 xULN if patient has a history of Gilbert's syndrome
Total bilirubin =< 1.5 upper limit of normal (ULN), with the exception of patients with Gilbert syndrome
Total bilirubin >1.5 x upper limit of normal (ULN). For patients with Gilbert's syndrome, total bilirubin >2.5 x ULN.
Total bilirubin =< 1.5 X institutional upper limit of normal (ULN) unless due to indirect hyperbilirubinemia related to Gilbert's syndrome or hemolysis, or to disease infiltration
Total bilirubin ? 1.5 x upper limit of normal (ULN) (Patients with documented diagnosis of Gilbert syndrome are eligible if total bilirubin < 3.0 x ULN)
Total bilirubin =< 3 X upper limit of normal (ULN), unless attributable to Gilbert syndrome
Total Bilirubin ? 1.5 x upper limit of normal (ULN), or patients diagnosed with Gilbert's syndrome, that have been reviewed and approved by the medical monitor
Total bilirubin ? 1.5 × upper limit of normal (ULN) (unless indirect bilirubin is elevated due to Gilbert's syndrome or hemolysis)
Bilirubin less than or equal to 2.5 x the upper limit of normal (ULN) (excluding Gilbert's syndrome)
Bilirubin < 1.5 x institutional upper limit of normal (ULN) or < 3 x ULN in patients with Gilbert's disease or liver involvement
Total bilirubin =< 3 X upper limit of normal (ULN) (except subjects with Gilbert syndrome, who can have total bilirubin up to 3.5 X ULN)
Total bilirubin =< 1.5 x upper limit of normal (ULN); =< 3 x ULN for patients with known Gilbert disease.
Bilirubin ?1.5 times the upper limit of normal (ULN) unless due to Gilbert Syndrome
Total bilirubin ? 1.5 X upper limit of normal (ULN) for current age (? 3 X ULN if increase in bilirubin is attributable to Gilbert's Syndrome)
Total bilirubin < 2.5 x upper limit of institutional normal reference range; patients with known Gilbert disease who have serum bilirubin =< 3 x upper limit of normal (ULN) may be enrolled
Bilirubin < 1.5 x institutional upper limit of normal (ULN) or < 3 x ULN in patients with Gilbert's disease or liver involvement
Total bilirubin < 1.5 x institutional upper limit of normal (with the exception of those with Gilbert syndrome
Total bilirubin =< 1.5 X upper limit of normal (ULN), for patients with congenital unconjugated hyperbilirubinemia (Crigler-Najjar syndrome type 1 and 2, Gilbert syndrome) that transient hyperbilirubinemia can occur due to physiological condition, as long as there is clear documentation of diagnosis, allowed to be enrolled if direct (conjugated) bilirubin is 1.5 X ULN
Total bilirubin < 2 x upper limits of normal (ULN) except Gilbert syndrome where < 3 x ULN is allowed
Total bilirubin =< 1.5 × institutional upper limit of normal (except for patients with Gilbert disease)
Total bilirubin =< 1.5 x institutional upper limit of normal (ULN) (except patients with Gilbert syndrome or liver metastasis who can have total bilirubin < 3.0 x ULN)
Total bilirubin =< 1.5 x upper limit of normal (ULN) except for patients with known Gilbert syndrome
Total bilirubin =< 1.5 X upper limit of normal (ULN), with the exception of patients with Gilbert syndrome who are required to have =< 3 X ULN
Total bilirubin =< 1.5 x upper limit of normal (ULN); for subjects with documented/suspected Gilbert's disease, bilirubin =< 3 x ULN
Total bilirubin =< 2.0 x upper limit of normal (ULN) (unless elevated bilirubin is related to Gilbert syndrome), within 14 day prior to registration
Total bilirubin =< 1.5 x upper limit of normal (ULN) (unless due to Gilbert syndrome, in which case it should be =< 3.0 x ULN)
Total bilirubin =< 1.5 x institutional upper limit of normal (ULN), in case of Gilbert's syndrome, =< 2 x ULN within 30 days prior to C1D1
Total bilirubin ? 2 times the upper limit of normal (ULN) unless due to Gilbert's disease
Total bilirubin ?1.5 x upper limit of normal (ULN) (except patients with documented Gilbert's syndrome);
Liver: total bilirubin ? 1.5 x the upper limit of normal (ULN; unless known Gilbert's syndrome); alanine aminotransferase ? 2.5 x ULN (? 5.0 x ULN in patients with liver metastases).
Total bilirubin > 1.5 times upper limit of normal (ULN) unless an alternate nonmalignant etiology exists (e.g., Gilbert's disease)
Total bilirubin >1.5 x upper limit of normal (ULN). For patients with Gilbert's syndrome total bilirubin >2.5 x upper limit of normal (ULN)
Total bilirubin < 2 x upper limits of normal (ULN) except Gilbert’ syndrome where < 3 x ULN is allowed
Serum total bilirubin =< 1.5 x upper limit of normal (ULN) (except for patients with documented Gilbert's syndrome)
Total bilirubin > 1.5 x upper limit of normal (ULN) unless related to Gilbert's syndrome or hemolysis
Total bilirubin < 1.5 x upper limit of normal (ULN) (Gilbert's allowed 3 x ULN)
Total bilirubin =< 2 mg/dl or =< 2.5 x upper limit of normal (ULN) for age (unless Gilbert's syndrome)
Adequate organ function defined as: bilirubin <2x upper limit of normal (ULN) (unless associated with Gilbert's syndrome), and ALT or AST <2.5x ULN.
Serum bilirubin < 2 mg/dL upper limit of normal (unless due to Gilbert's disease; patient with this disease should have a right upper quadrant ultrasound evaluation before treatment)
Total serum bilirubin =< 1.5 x upper limit of normal (ULN), unless due to Gilbert's syndrome
Total bilirubin =< 1.5 x upper limit of normal (ULN) or =< 3 x ULN if documented hepatic involvement with lymphoma, or =< 5 x ULN if history of Gilbert's syndrome, without use of growth factor support for 1 week
Total bilirubin greater the upper limit of normal (ULN; unless the subject has documented Gilbert's syndrome).
Total bilirubin must be less than or equal to 1.5 x ULN (upper limit of normal) for the lab unless the patient has a bilirubin elevation greater than 1.5 x Upper limit of normal (ULN) to 3 x ULN due to Gilbert's disease or similar syndrome involving slow conjugation of bilirubin; and
total bilirubin: ?2 x upper normal limit (UNL) (patients with Gilbert's disease are eligible, hyperbilirubinemia is intermittent & indirect)
To be performed within 14 days prior to day 1 of protocol therapy: total bilirubin =< 1.5 x upper limit of normal (ULN) (=< for Gilbert's syndrome or documented hepatic involvement by lymphoma)
Total bilirubin ? 2 times the upper limit of normal (ULN) unless due to Gilbert's disease
Total bilirubin =< 2 x upper limit of normal (ULN) (unless elevated bilirubin is related to Gilbert syndrome).
Total bilirubin (TBL) =< 1.5 x upper limit of normal (ULN) except patients with documented Gilbert's syndrome (> 3 x ULN), within 28 days of day 0.
Total bilirubin <=<1.5 x the upper limit of normal unless considered due to Gilbert's syndrome
Total bilirubin within normal ranges unless associated with hepatobiliary metastases or Gilbert syndrome, then total bilirubin =< 2 x upper limit of normal (ULN)
Total bilirubin < 1.5 x institutional upper limit of normal (ULN) (except for patients with Gilbert's syndrome and elevations of indirect bilirubin)
Total bilirubin ? 1.5 × upper limit of normal range except in cases of Gilbert's disease and liver metastases.
Serum bilirubin =< 1.5 x upper limit of normal (ULN) unless attributable to Gilbert's syndrome
Total bilirubin =< 1.5 x institutional upper limit of normal (ULN) (or =< 2.0 x ULN in patients with documented Gilbert's syndrome)
Bilirubin ? 1.5 x upper limit of normal (ULN) except for unconjugated hyperbilirubinemia or Gilbert's syndrome;
Serum bilirubin at least 1.5 × upper limit of normal (ULN) or at least 3 × ULN if Gilbert's disease is documented
Patient has > 1.5 x upper limit of normal (ULN) total bilirubin unless history of Gilbert's syndrome
Total bilirubin less than or equal to 1.5 X the upper limit of normal (ULN) except for unconjugated hyperbilirubinemia of Gilbert's syndrome
Bilirubin < 1.5 X ULN (the upper limit of normal) (subjects with confirmed Gilbert disease as the cause of their elevated bilirubin are to be permitted)
Total bilirubin =< 1.5 x upper limit of normal (ULN) or =< 3 x ULN if documented hepatic involvement with lymphoma, or =< 5 x ULN if history of Gilbert's syndrome
Total bilirubin =< 1.5 x upper limit of normal (ULN, unless due to Gilbert syndrome, in which case it should be =< 3.0 x ULN)
Serum bilirubin =< 1.5 x institutional upper limit of normal (ULN); (unless Gilbert's syndrome, without concurrent clinically significant liver disease), obtained within 14 days prior to first treatment
Bilirubin < 1.5 x upper limit of normal (unless Gilbert's syndrome)
Total bilirubin level <= 1.5 x the upper limit of normal (ULN), unless the patient has known Gilbert's disease
Serum total bilirubin ?1.5 × upper limit of normal (ULN), unless considered due to Gilbert's disease or disease involvement following approval by the Medical Monitor;
Bilirubin ? 1.5 x upper limit of normal (ULN); does not apply to patients with Gilbert's syndrome
Bilirubin < 1.5 x upper limit of normal (ULN) except for unconjugated hyperbilirubinemia or Gilbert's syndrome
Serum bilirubin < 1.5 x upper limit of normal (ULN) (except for patients with documented Gilbert's disease)
Bilirubin less than or equal 1.5 x upper limit of normal (ULN) except for unconjugated hyperbilirubinemia or Gilbert's syndrome
Serum bilirubin =< 1.5 x upper limit of normal (ULN) unless attributable to Gilbert's syndrome
Total bilirubin =< 1.5 X institutional upper limit of normal (unless due to Gilbert's disease)
Serum bilirubin >= 1.5 x upper limit of normal (ULN) or for patients with Gilbert's disease, >= 3 mg/dL at the screening visit
Serum bilirubin =< 1.5 x upper limit of normal (ULN) unless deemed elevated secondary to lymphoma involvement of the liver or known Gilbert's syndrome
Serum bilirubin =< 1.5 x institutional upper limit of normal (ULN) (=< 3 x institutional ULN in patients with Gilbert's syndrome)
Total bilirubin ? 2 × upper limit of normal (ULN) or < 3 x ULN for patients with Gilbert-Meulengracht Syndrome
Serum bilirubin =< 1.5 x institutional upper limit of normal (ULN); (unless Gilbert's syndrome, for which bilirubin =< 3 x institutional upper limit of normal [ULN], without concurrent clinically significant liver disease), obtained within 14 days prior to first treatment
Total bilirubin =< 1.5 x upper limit of normal, unless known Gilbert's syndrome
Total bilirubin =< 1.5 times upper limit of normal (ULN) institutional limits (unless Gilbert's disease)
Total bilirubin < 1.5 times upper limit of normal (ULN) institutional limits (unless Gilbert's disease)
Bilirubin =< 1.5 times the upper limit of normal (x ULN) for the institution or =< 3 mg/dl in a subject with Gilbert syndrome
Total bilirubin =< 1.5 x upper limit of normal (ULN) except for patients with known Gilbert syndrome
Total bilirubin =< 1.5 times upper limit normal (ULN) other than cases of Gilbert disease
Cohort A: Total bilirubin less than 1.5 x upper limit of normal (ULN) (unless known Gilbert's disease)
Bilirubin within 1.5 x the upper limit of normal for age, with the exception of those with Gilbert syndrome
Total bilirubin <1.5 x upper limit of normal (ULN), unless considered due to Gilbert's syndrome
Bilirubin less than or equal to 1.5 times the upper limit of normal (ULN) except for unconjugated hyperbilirubinemia of Gilbert's syndrome.
Total bilirubin =< 1.5 x upper limit of normal (ULN)\r\n* Except in case of Gilbert disease
Total bilirubin (TBL) < 1.5 × upper limit of normal (ULN; except for subjects with documented Gilbert's syndrome)
Bilirubin ?1.5 × upper limit of normal (ULN) except for unconjugated hyperbilirubinemia or Gilbert's syndrome;
Total bilirubin < 1.5 x upper limit of normal (ULN) (unless known Gilbert syndrome)
Total bilirubin =< 1.5 x upper limit of normal (ULN) (except for Gilbert's syndrome)
Serum bilirubin =< 1.5 x institutional upper limit of normal (ULN) (=< 3 x institutional ULN in patients with Gilbert's syndrome)
Total bilirubin < 1.5 × upper limit of normal (ULN); does not apply to patients with Gilbert's syndrome
Total bilirubin <1.5x the upper limit of normal unless considered due to Gilbert's syndrome in which case, <3x the upper limit of normal
Total serum bilirubin > 1.5 times upper limit of normal; increased serum bilirubin due to Gilbert's syndrome is permitted
Total bilirubin =< 1.5 x upper limit of normal (ULN) (unless known Gilbert's syndrome)
Bilirubin ?1.5 × upper limit of normal (ULN) except for unconjugated hyperbilirubinemia or Gilbert's syndrome.
Serum bilirubin ? 1.5 x ULN, except in subjects with Gilbert's Syndrome who must have a total bilirubin < 3 mg/dL
Total bilirubin =< 1.5 mg/dL (=< 2.0 in patients with known Gilbert's syndrome)
Serum bilirubin <1.5 mg/dL (except subjects with Gilbert's syndrome who may have total bilirubin <3.0 mg/mL)
Obtained within 14 days prior to C1D1: Total Bilirubin =< 1.5 x ULN, except subjects with Gilbert syndrome, who can have total bilirubin < 3.0 mg/dL
Bilirubin ?2 x ULN (except subjects with Gilbert's syndrome, who must have total bilirubin < 3.0 mg/dL (<52 µmol/L))
Total bilirubin =< 1.5 x ULN (except subjects with Gilbert syndrome, who must have total bilirubin < 3.0 mg/dL) within 14 days prior to first dose of protocol-indicated treatment.
Within 14 days of the first dose of study drug: Total bilirubin =< 1.5 x ULN (except patients with Gilbert syndrome who must have total bilirubin < 3.0 mg/dL)
Bilirubin =< 1.5 x ULN (except subjects with Gilbert Syndrome, who can have total bilirubin < 3.0 mg/dL).
Total Serum Bilirubin ? 1.5 x ULN (< 3.0 mg/dL if subject has Gilbert's syndrome)
Obtained within 14 days prior to randomization/registration: total Bilirubin =< 1.5 x ULN (except subjects with Gilbert Syndrome, who can have total bilirubin < 3.0 mg/dL)
Total bilirubin ? 1.5 mg/dl, except in subjects with Gilbert's syndrome.
Total bilirubin =< 1.5 x ULN (except subjects with Gilbert syndrome, who can have total bilirubin < 3.0 mg/dL)
Total bilirubin =< 1.5 x ULN (except subjects with Gilbert Syndrome, who can have total bilirubin < 3.0 mg/dL) within 14 days of registration
Total bilirubin =< 2 mg/dL or direct bilirubin =< ULN for those with total bilirubin > 2 x ULN; subjects with Gilbert syndrome will be eligible if total bilirubin is < 3.0 mg/dL
Total bilirubin =< 1.5 x ULN within 14 days of study registration (except subjects with Gilbert Syndrome who must have total bilirubin < 3.0 mg/dl).
Obtained within 21 days prior to randomization/registration: Total bilirubin =< 1.5 x ULN (except subjects with Gilbert syndrome, who can have total bilirubin < 3.0 mg/dL).
Bilirubin =< 1.5 x ULN (except subjects with Gilbert syndrome, who can have total bilirubin < 3.0 mg/dL)
Total bilirubin =< 1.5 x ULN (except subjects with Gilbert syndrome, who can have total bilirubin < 3.0 mg/dL)
Total bilirubin (Bili T) =< 1.5 x ULN (although patients with Gilbert syndrome can have total bilirubin < 3.0 mg/dL), within 30 days before study registration
Total bilirubin =< 1.5 x ULN (except subjects with Gilbert syndrome, who can have total bilirubin < 3.0 mg/dL) within 14 days prior to first dose
Serum total bilirubin =< 1.5 x ULN (subjects with Gilbert syndrome can have a total bilirubin < 3 mg/dL), performed within 14 days of protocol registration
Obtained within 14 days of randomization: Total bilirubin =< 1.5 x ULN (except subjects with Gilbert Syndrome who must have total bilirubin < 3.0 mg/dL)
Total bilirubin > 1.5 x ULN (except subjects with Gilbert syndrome, who can have total bilirubin < 3.0 mg/dL)
Total bilirubin =< 1.5 x ULN (except subjects with Gilbert syndrome, who can have total bilirubin < 3.0 mg/dL)
Serum total bilirubin =< 1.5 X ULN OR except subjects with Gilbert syndrome, who can have total bilirubin < 3.0 mg/dL
Total bilirubin =< 1.5 x ULN (except subjects with Gilbert syndrome, who can have total bilirubin < 3.0 mg/dL)
Total bilirubin =< 1.5 x ULN (except subjects with Gilbert syndrome, who can have total bilirubin < 3.0 mg/dL) or =< 2 x ULN if lenalidomide is being prescribed; should be obtained within 21 days prior to enrollment
Bilirubin ? 2.0 x ULN, (except patients with Gilbert's Syndrome, who must have a total bilirubin less than 3.0 mg/dL)
Total Bilirubin =< 1.5 x ULN (except subjects with Gilbert syndrome, who can have total bilirubin < 3.0 mg/dL)
Total bilirubin =< 2 mg/dL, except for patient's with Gilbert's syndrome
Total bilirubin =< 1.5 mg/dL x upper limit of normal (ULN) (except subjects with Gilbert syndrome who can have total bilirubin =< 3.0 mg/dL)
Total bilirubin =< 1.5 x ULN; except subjects with Gilbert syndrome who can have total bilirubin < 3.0 mg/dL) obtained within 14 days of first treatment
Total bilirubin =< 1.5 x ULN (except subjects with Gilbert syndrome, who can have total bilirubin < 3.0 mg/dL) obtained within 14 days prior to randomization/registration
Bilirubin =< 1.5 x ULN (except subjects with Gilbert syndrome, who can have total bilirubin < 3.0 mg/dL)
Total bilirubin =< 1.5 x ULN (except subjects with Gilbert syndrome, who can have total bilirubin < 3.0 mg/dL)
Total bilirubin less than or equal to 2.0 mg/dl, except in patients with Gilbert's syndrome who must have a total bilirubin less than 3.0 mg/dl (Turnstile II - Chemotherapy/Cell Infusion - Inclusion Criteria)
Total bilirubin ? 2 mg/dL (except in patients with Gilbert's Syndrome)
Total bilirubin ? 2 mg/dL (except in patients with Gilbert's Syndrome)
Total bilirubin ? 1.5 × (< 3 mg/dL for subjects with Gilbert's disease)
Total bilirubin =< 1.5 x ULN (except subjects with Gilbert syndrome, who can have total bilirubin < 3.0 mg/dL)
Obtained within 30 days prior to registration: Bilirubin 1.5 =< (ULN)\r\n* Except subjects with Gilbert syndrome, who can have total bilirubin < 3.0 mg/dL
Bilirubin =< 1.5 mg/dl, in patients with Gilbert's syndrome, a total bilirubin =< 3.0 mg/dL
Total bilirubin less than or equal to 2.0 mg/dL, except in patients with Gilbert's syndrome who must have a total bilirubin less than 3.0 mg/dL
Total bilirubin less than or equal to 2.0 mg/dL, except in patients with Gilbert's syndrome who must have a total bilirubin less than 3.0mg/dL
Serum total bilirubin < 2 mg/dl; patients with Gilbert syndrome are excluded from the requirement of a normal bilirubin
Bilirubin =< 2 x ULN (except subjects with Gilbert syndrome who must have total bilirubin < 3.0 mg/dL)
Bilirubin less than 1.5 mg/dL; (except in patients with Gilbert's syndrome, who must have a total bilirubin less than 3.0 mg/dL)
Serum total bilirubin > 1.5 × ULN or > 3.0 mg/dL for subjects with documented Gilbert's syndrome
Bilirubin within normal limits (except subjects with Gilbert's syndrome, who must have a total bilirubin < 3.0 mg/dL)
Bilirubin =< 1.5 x ULN; for patients with Gilbert's syndrome, bilirubin =< 3.0 mg/dL is acceptable
Total bilirubin ? 3 x ULN, (except patients with Gilbert's Syndrome, who must have a total bilirubin less than 3.0 mg/dL)
Total bilirubin =< 1.5 x ULN (except subjects with Gilbert Syndrome who must have total bilirubin < 3.0 mg/dL)
Total bilirubin > 2.0 mg/dl, except in patients with Gilbert's syndrome whose total bilirubin must not exceed 3.0 mg/dl) deemed by investigator to be irreversible
Total bilirubin > 2.0 mg/dl, except in patients with Gilbert's syndrome whose total bilirubin must not exceed 3.0 mg/dl)
Total bilirubin =< 1.5 x ULN (< 3 mg/dL for subjects with Gilbert's disease)
Total Serum Bilirubin ? 1.5 x ULN (< 3.0 mg/dL if subject has Gilbert's syndrome)
Total bilirubin ? 1.5 × ULN (except in patients with Gilbert Syndrome who can have total bilirubin < 3.0 mg/dL).
Serum bilirubin ? 1.5 x ULN, except in patients with Gilbert's Syndrome who must have a total bilirubin < 3 mg/dL
Total bilirubin =< ULN (except subjects with Gilbert syndrome who must have total bilirubin < 3.0 mg/dl)
Serum total bilirubin < 2 x ULN (except patients with Gilbert syndrome, who can have total bilirubin < 3.0 mg/dL)
Bilirubin =< 2.0 x ULN, (except patients with Gilbert's syndrome, who must have a total bilirubin less than 3.0 mg/dL)
COHORT A: Bilirubin =< 1.5 x ULN (except patients with Gilbert's syndrome, who must have a total bilirubin less than 3.0 mg/dL)
COHORT B: Bilirubin =< 1.5 x ULN (except patients with Gilbert's syndrome, who must have a total bilirubin less than 3.0 mg/dL)
Bilirubin =< 1.5 mg/dL (OR in patients with Gilbert's syndrome, a total bilirubin =< 3.0) (within 16 days before starting therapy)
Total Bilirubin >1.5x ULN (except subjects with Gilbert syndrome, total bilirubin <3.0 mg/dL)
Total bilirubin =< 1.5 x ULN (except subjects with Gilbert syndrome, who can have total bilirubin < 3.0 mg/dL)
Total bilirubin ?1.5 x ULN, except in patients with Gilbert's Syndrome who must have a total bilirubin <3 mg/dL (51.3 ?mol/L)
Total bilirubin <1.5 x ULN, except for patients with Gilbert's disease who are eligible if total bilirubin ? 3mg/dL.
Adequate hepatic and renal function laboratory values within 14 days prior to registration: Total bilirubin =< 1.5 mg/dL except for patients with a history of elevated total bilirubin, such as in Gilbert's
Serum total bilirubin >2.0 mg/dL (with the exception of Gilbert's Syndrome)
Total bilirubin =< 3 x ULN (except subjects with Gilbert syndrome, who can have total bilirubin < 3.0 mg/dL)
Serum total bilirubin < 2 mg/dl; patients with Gilbert syndrome are excluded from the requirement of a normal bilirubin
Total bilirubin < 1.5 x ULN (except subjects with Gilbert syndrome who can have total bilirubin < 3.0 mg/deciliter) should be obtained with 28 days prior to randomization
Total bilirubin <1.5 mg/dl, except in subjects with Gilbert's syndrome
Total bilirubin >ULN: Subjects with Gilbert's syndrome are allowed if total bilirubin is <3.0 mg/dL and direct bilirubin is ?ULN,
Bilirubin less than 1.5 mg/dL; (except in patients with Gilbert's syndrome, who must have a total bilirubin less than 3.0 mg/dL)
Bilirubin =< 3.0 x ULN (except patients with Gilbert's syndrome, who must have a total bilirubin less than 3.0 mg/dL)
Total bilirubin =< 1.5 x ULN; (except subjects with Gilbert syndrome, who can have total bilirubin < 3.0 mg/dL)
Total bilirubin ? 1.5 x ULN (except subjects with Gilbert syndrome, who can have total bilirubin < 3.0 mg/dL)
T. bilirubin < 2 mg/dl (Patients with Gilbert Syndrome total bilirubin <3xULN and direct bilirubin ? 35%)
Serum total bilirubin ? 2.5 mg/dL (43 ?mol/L), except for subjects with Gilbert's syndrome.
Total bilirubin =< 2.0 mg/dL (except patients with Gilbert syndrome, who can have total bilirubin < 3.0 mg/dL)
Known history of Gilbert's syndrome
Abnormal glucuronidation of bilirubin, known Gilbert's syndrome
Subjects with Gilbert's syndrome;
Participants with Gilbert's syndrome will be eligible for the study
Have a history of Gilbert's syndrome.
Known history of Gilbert's syndrome.
Known history of Gilbert's Syndrome.
Patients with Gilbert's disease.
Bilirubin =< 2 X ULN (3 X if known history of Gilbert's syndrome)
Patients with known Gilbert syndrome are not eligible
History of Gilbert's syndrome
Known or suspected Gilbert's disease at the time of randomization.
History of Gilbert syndrome
History of Gilbert's syndrome
Known Gilbert's syndrome
Known history of Gilbert's Syndrome or any current hyperbilirubinemia of any cause
Has a known history of Gilbert's Syndrome
Diagnosis of Gilbert's disease
History of Gilbert's syndrome
History of Gilbert's syndrome.
History of Gilbert's syndrome
History of Gilbert's syndrome.
4. Known history of Gilbert's Syndrome.
Patients who have a diagnosis of Gilbert's disease
Total bilirubin ? 1.5 x ULN (unless has Gilbert's syndrome)
Re-registration: total bilirubin =< 1.5 x ULN in absence of Gilbert disease (total bilirubin =< 3 x ULN with Gilbert); if hyperbilirubinemia is clearly attributed to liver metastases, total bilirubin =< 3 x ULN is permitted
Total bilirubin =< 1.5 x ULN (except subjects with Gilbert syndrome, who can have total bilirubin < 3.0 x ULN), within 4 weeks of randomization
Within 10 days of treatment initiation: Bilirubin =< 1.5 X IULN\r\n* Bilirubin > 1.5 x ULN is allowed in subjects with conjugated bilirubin disorder or Gilbert's syndrome
Bilirubin ? 1.5 × ULN unless evidence of Gilbert's disease in which case < 3 x ULN
Bilirubin < 1.5 × ULN except in patients with Gilbert's disease Renal Function
Total bilirubin > 1.5 times ULN (patients with confirmed Gilbert's syndrome may be included in the study)
Bilirubin ? 1.5 x ULN (unless considered due to Gilbert's syndrome or hemolysis)
Bilirubin =< 1.5 x ULN (unless documented Gilbert's disease), within 14 days of registration
Bilirubin ? 2.5 × ULN (? 4 × ULN for subjects with Gilbert's disease);
Patients with hyperbilirubinemia clinically consistent with an inherited disorder of bilirubin metabolism (e.g., Gilbert syndrome) will be eligible at the discretion of the principal investigator if total bilirubin is =< 1.5 X ULN
Total bilirubin less than or equal to 1.5 X ULN except for unconjugated hyperbilirubinemia of Gilbert's syndrome
Serum bilirubin > 1.5 × ULN; bilirubin up to 3 x ULN is permitted in individuals with documented liver involvement by lymphoma or if due to known Gilbert syndrome or other organ system that may place the patient at undue risk to undergo treatment
Total bilirubin =< 1.5 x ULN within 28 days of treatment initiation and must be independent of hematopoietic growth factor support\r\n* Note: patients with hyperbilirubinemia clinically consistent with an inherited disorder of bilirubin metabolism (eg, Gilbert syndrome) will be eligible at the discretion of the principal investigator
total bilirubin must be ? ULN for the lab unless the patient has a bilirubin elevation > ULN to 1.5 x ULN due to Gilbert's disease or similar syndrome involving slow conjugation of bilirubin; and
Total bilirubin ? 1.5 × institutional ULN (total bilirubin of ? 3 x institutional ULN in subjects with documented Gilbert's syndrome).
Total serum bilirubin =< 1.5 x ULN unless the patient has documented Gilbert syndrome
Obtained within 14 days prior to registration: Total bilirubin =< 1.5 ULN (unless documented Gilbert's disease)
Total bilirubin (TBL) < 2x ULN (unless Gilbert's disease or if liver involvement with lymphoma)
Within 14 days of randomization: Bilirubin =< ULN (unless documented Gilbert's disease)
Total bilirubin ?1.5 times the ULN (or ?3 x ULN, if patient has Gilbert syndrome)
Total bilirubin < 1.5 x ULN (or =< 3 x ULN for patients with documented Gilbert syndrome)
Total bilirubin =< 1.5 x ULN\r\n* Except in the case of Gilbert disease, in which case total bilirubin must be =< 3 x ULN
Total serum bilirubin ? 1.5 x ULN, (except for patients with known Gilbert's Syndrome ? 3 x ULN is permitted)
Within 4 weeks before enrollment: Total bilirubin =< 2.5 x ULN; except if the elevation is due to Gilbert's syndrome
Total serum bilirubin < 1.5 x ULN, unless the patient has documented Gilbert syndrome
Within 14 days prior to registration: Bilirubin =< 1.5 x ULN; for patients with Gilbert's syndrome, bilirubin =< 3 x ULN is acceptable
Bilirubin =< 1.5 x ULN (unless documented Gilbert's disease) within 14 days of cycle 1 day 1
Total bilirubin ?1.5 × ULN except for unconjugated hyperbilirubinemia or Gilbert's syndrome
• Bilirubin ? 1.5 times institutional ULN; does not apply to patients diagnosed with Gilbert's syndrome.
Total serum bilirubin =< 1.5 x ULN unless the patient has documented Gilbert syndrome. If organ function abnormalities are considered due to tumor, total serum bilirubin must be =< 2 x ULN
Liver function: ALT and AST ? 2.5 × ULN; Total bilirubin ? 1.5 × ULN (or ? 3 times ULN for subjects with documented Gilbert's syndrome or for whom indirect bilirubin concentrations suggest an extra-hepatic source of elevation)
Total bilirubin ?1.5 x ULN (does not include patients with Gilbert's Disease)
Total bilirubin > 1.5 x ULN (Patients with a history of Gilbert's syndrome may participate if total bilirubin is less than or equal to 1.5 x ULN and the AST/ALT and alkaline phosphatase meet the protocol-specified levels for eligibility)
Total bilirubin is less than or equal to ULN, except the case in which the elevated total bilirubin is not a sign of liver disease, such as the Gilbert Syndrome, in which case a total bilirubin less than or equal to 2 x ULN is acceptable
Total bilirubin ? 1 x ULN (unless elevated due to Gilbert's syndrome or extrahepatic source as denoted by increased indirect bilirubin fraction. Subjects with ?1 x ULN will be tested for direct bilirubin fraction so that the indirect fraction can be calculated).
Total serum bilirubin ?1.5 × ULN, unless due to Gilbert's syndrome
Total bilirubin < 1.5 times ULN unless due to Gilbert's disease
ADDITIONAL CRITERIA FOR STUDY CONTINUATION: Total bilirubin =< 1.5 x ULN (except subjects with Gilbert Syndrome, who can have total bilirubin =< 2.0 x ULN)
Total bilirubin (T-Bil) =< 1.5 X ULN (prior diagnosis or past history consistent with Gilbert's syndrome is an exception)
Bilirubin equal or less than 1.5 (unless Gilbert's syndrome)
Total bilirubin > 1.5 x ULN (or > 3 x ULN for patients with documented Gilbert syndrome)
Total bilirubin >= 1.5 x ULN (subjects with Gilbert's syndrome can have bilirubin of up to 1.5 x ULN), OR
Serum bilirubin < ULN (exception of Gilbert disease)
Total bilirubin =< 2 x ULN (except patients with documented Gilbert's syndrome)
Hepatic Parameters: Total Bilirubin </= ULN; Alkaline Phosphatase </= 2 x ULN; AST and ALT </= 2 x ULN If the patient has a history of Gilbert's Syndrome, check direct and indirect bilirubin. If in the judgment of the attending medical oncologist it is safe to treat the patient, the patient will be considered eligible for this criteria.
Total serum bilirubin?1.5 x ULN, (except for patients with known Gilbert's Syndrome?3 x ULN is permitted)
Total bilirubin < 3 x ULN (except if confirmed history of Gilbert's disease)
bilirubin < 1.5 ULN, excluding Gilbert's syndrome
Total bilirubin > ULN (except in patients diagnosed with Gilbert's disease).
Total Bilirubin ? 1.0 x ULN (unless elevated secondary to benign conditions such as Gilbert's disease)
Total bilirubin =< 2 x ULN or =< 3 x ULN if Gilbert's disease).
Bilirubin =< 1.5 x ULN (=< 3 x ULN for patients with Gilbert syndrome)
Total bilirubin =< 2 x ULN (patients with Gilbert syndrome may be included at the discretion of the principal investigator [PI] or where hemolysis has been excluded)
Total bilirubin =< 1.5 x ULN; unless presence of Gilbert's syndrome, liver involvement by CLL or MM, or stable chronic liver disease per investigator's assessment
Total bilirubin < 1.5 X ULN; patients with Gilbert's disease are exempt from this criteria
Bilirubin less than or equal to 1.5 (except if due to Gilbert's disease)
Total serum bilirubin ?2.0 x ULN unless the subject has documented Gilbert syndrome;
Total serum bilirubin ? 1.5 x ULN unless the patient has documented Gilbert syndrome and AST and ALT ? 2.5 x ULN.
T.Bili. ? 1.5 x ULN (except in patients diagnosed with Gilbert's disease).
Total serum bilirubin ? 2.0 × ULN (unless the subject has documented Gilbert Syndrome)
Serum total bilirubin ?1.5 x ULN (unless subject had documented Gilbert's Syndrome)
Total bilirubin ? 2.0 X ULN, or ? 3.0 X ULN (for patients with Gilbert's Syndrome)
Patients with Gilbert syndrome and bilirubin < 2 x ULN and normal AST/ALT
Bilirubin ? 1.5 × ULN except for cases of documented or suspected Gilbert's disease, in which bilirubin must be ? 5 × ULN
Serum bilirubin =< 1.5 x ULN or =< 3.0 x ULN for patients with Gilbert syndrome or documented hepatic involvement
Total bilirubin < 1.5 x ULN (except for subjects with documented Gilbert's syndrome)
Total bilirubin =< 2 x ULN (except patients with documented Gilbert's syndrome)
Total bilirubin <1.5 x the institutional ULN, unless the subject has documented unconjugated bilirubin disorder such as Gilbert's syndrome.
Total bilirubin =< 1.5 x ULN (excepting Gilbert's syndrome)
Total bilirubin within normal limits (WNL) for the institution, unless the bilirubin abnormality is considered due to Gilbert's syndrome.
bilirubin less than or equal to 1.5 × ULN for all subjects age 75 and older* Subjects who are less than 75 years of age must have a bilirubin of less than 3.0 × ULN * Unless considered due to leukemic organ involvement. Note: Subjects with Gilbert's Syndrome may have a bilirubin greater than 1.5 × ULN per discussion between the investigator and AbbVie medical monitor.
Total serum bilirubin ?1.5 x ULN (<3.0 x ULN for participants with Gilbert syndrome)
Total bilirubin within normal ranges unless associated with hepatobiliary metastases or Gilbert syndrome, then total bilirubin ? 2 x ULN
Total bilirubin ? 1.5 × institutional ULN except in the presence of Gilbert Syndrome
Total bilirubin =< 1.5 x ULN (patients with elevated bilirubin due to Gilbert's disease will not be excluded)
Total bilirubin =< 1.5 X ULN (except in patients with Gilbert's)
Total bilirubin < 1.5 x ULN\r\n* Does not apply to patients with isolated hyperbilirubinemia (e.g., Gilbert's disease) grade < 3
Bilirubin ? 1.5 × ULN except for subjects with documented Gilbert's disease, ? 2.5 × ULN;
Total bilirubin ?1.5 x ULN (except for subjects with documented Gilbert's syndrome)
Total serum bilirubin ? 2.0 × ULN (unless the subject has documented Gilbert Syndrome)
Total bilirubin =< 1.5 x ULN unless the patient has documented Gilbert syndrome
Serum bilirubin ? 2 x ULN unless due to Gilbert's syndrome or hemolysis or considered to be related to leukemia;
Total bilirubin values <1.5 x ULN unless the bilirubin is principally unconjugated (in the context of hemolysis) or there is documented Gilbert's disease.
Total bilirubin < 1.5 × ULN (except for subjects with documented Gilbert's syndrome)
Bilirubin ?2.0 times ULN, unless participant has known Gilbert's syndrome
Bilirubin ? 2.0 times ULN, unless subject has known Gilbert's syndrome
For patients with Gilbert's syndrome total bilirubin > 2.5 x ULN
Total bilirubin ?1.5 x ULN, unless secondary to Gilbert's disease
Total bilirubin >1.5x ULN (unless due to Gilbert's Syndrome)
Serum bilirubin < 1.5 x ULN unless due to Gilbert's syndrome. o Serum bilirubin ? 1.0 x ULN unless due to Gilbert's syndrome, Treatment Arm B only (CC-122 in combination with ibrutinib)
Serum bilirubin =< 1.5 x ULN (unless secondary to Gilbert's disease)
Total serum bilirubin ? ULN unless due to Gilbert's Syndrome;
Bilirubin ? 1.5 × ULN except for cases of documented or suspected Gilbert's disease, in which bilirubin must be ? 5 × ULN
Total bilirubin ? 1.5 × ULN except in cases of Gilbert's disease and liver metastases.
Total bilirubin ? 1.5 X ULN. Patients with elevated bilirubin known to be due to Gilbert's disease may be enrolled after approval from the medical monitor, and
Bilirubin ? 1.5 × ULN except for cases of documented or suspected Gilbert's disease, in which bilirubin must be ? 5 × ULN
Total bilirubin ? 1.5 × ULN except subjects with documented Gilbert's syndrome (> 3 × ULN) or liver metastasis, who must have a baseline total bilirubin ? 3.0 mg/
Total bilirubin > 1.5× the ULN for the institution, unless considered due to Gilbert's Syndrome
Total bilirubin ?2.0 times the ULN for the institution, unless considered due to Gilbert's syndrome;
Total bilirubin ?2 x ULN (?5 x ULN if considered due to Gilbert's syndrome or hemolysis)
Total bilirubin < 1.5 x ULN (< 3.0 x ULN for subjects with documented Gilbert's Disease or for whom the indirect bilirubin level suggests an extrahepatic source of elevation);
Patient has > 1.5 x ULN total bilirubin, unless history of Gilbert's syndrome
Total bilirubin ?1.5 X ULN unless considered due to Gilbert's syndrome
Total bilirubin ?1.5X ULN, unless considered due to Gilbert's syndrome
Total bilirubin ?2X ULN, unless considered due to Gilbert's syndrome
Total bilirubin ?2X ULN, unless considered due to Gilbert's syndrome
Total bilirubin > 1.5 x ULN (unless due to lymphoma or isolated, predominantly indirect hyperbilirubinemia due to Gilbert's syndrome)
Bilirubin equal or less than 1.5 (unless Gilbert's Syndrome)
Bilirubin =< ULN (unless documented Gilbert's disease), obtained within 14 days prior to treatment start
- Total bilirubin < 1.5 x ULN (< 3 x ULN in patients with known/suspected Gilbert's disease)
Total bilirubin ?1.5 x ULN, except in subjects with documented Gilbert's Syndrome, who must have a total bilirubin ?3 x ULN
- Total bilirubin < 1.5 x ULN (< 3 x ULN in patients with known/suspected Gilbert's disease)
Total bilirubin >1.5 x ULN (unless Gilbert's syndrome or extrahepatic source as denoted by increased indirect bilirubin fraction)
Bilirubin >1.5 x ULN, unless prior diagnosis and documentation of leukemic organ involvement, ongoing hemolysis, or Gilbert's syndrome
Patients has current active hepatic or biliary disease (with exception of patients with Gilbert’s syndrome, asymptomatic gallstones, or stable chronic liver disease per investigator assessment)
Must not have active liver or biliary disease (with the exception of Gilbert’s syndrome or asymptomatic gallstones, liver metastases or otherwise stable chronic liver disease per investigator assessment);\r\n* Note: Stable chronic liver disease should generally be defined by the absence of ascites, encephalopathy, coagulopathy, hypoalbuminemia, esophageal or gastric varices, persistent jaundice, or cirrhosis
Current active liver or biliary disease.
Subjects who have current active hepatic or biliary disease (with exception of patients with Gilbert's syndrome, asymptomatic gallstones, liver involved with lymphoma or stable chronic liver disease per investigator’s assessment)
Adequate Liver Function defined as total bilirubin <=1.5 x upper limit of normal (ULN) for age, serum glutamic-pyruvic transaminase (SGPT) Alanine transaminase (ALT) <=2.5 x ULN (for the purpose of this study, the ULN for SGPT is 45 U/L), Serum albumin >=2 g/dL. Must not have active liver or biliary disease (with the exception of Gilbert's syndrome or asymptomatic gallstones, liver metastases or otherwise stable chronic liver disease per investigator assessment). NOTE: Stable chronic liver disease should generally be defined by the absence of ascites, encephalopathy, coagulopathy, hypoalbuminaemia, oesophageal or gastric varices, persistent jaundice, or cirrhosis. No known positivity of hepatitis B surface antigen (HBsAg), or of positive hepatitis C antibody.
Acute or currently active hepatic or biliary disease requiring antiviral therapy (with the exception of Gilbert’s syndrome, asymptomatic gallstones, liver metastases, or stable chronic liver disease per investigator assessment)
EXCLUSION CRITERIA FOR REGISTRATION: Acute or currently active hepatic or biliary disease requiring antiviral therapy (with the exception of patients with Gilbert’s syndrome, asymptomatic gallstones, liver metastases, or stable chronic liver disease per investigator assessment)
Acute or chronic uncontrolled renal disease, pancreatitis or liver disease (with exception of patients with Gilbert's Syndrome, asymptomatic gall stones, liver metastases, or stable chronic liver disease per investigator assessment)
Subjects who have current active hepatic or biliary disease (with exception of patients with Gilbert's syndrome, asymptomatic gallstones, liver involvement or stable chronic liver disease per investigator assessment)
Current active hepatic or biliary disease (with exception of patients with Gilbert's syndrome, asymptomatic gallstones, or stable chronic liver disease per investigator assessment)
Current active liver or biliary disease (with the exception of Gilbert's syndrome or asymptomatic gallstones or otherwise stable chronic liver disease per investigator's assessment)
Subjects who have current active hepatic or biliary disease (with exception of patients with Gilbert's syndrome, asymptomatic gallstones, liver metastases or stable chronic liver disease per treating physician assessment), sources for the determination of clinical significance by the treating physician will be included in the subject’s medical record
Subjects who have current active hepatic or biliary disease (with exception of patients with Gilbert's syndrome, asymptomatic gallstones, liver metastases or stable chronic liver disease per investigator assessment)
Have acute or currently active/requiring anti-viral therapy hepatic or biliary disease (with the exception of patients with Gilbert's syndrome, asymptomatic gallstones, liver metastases or stable chronic liver disease per investigator assessment)
Patients who have current active hepatic or biliary disease (with exception of patients with Gilbert's syndrome, asymptomatic gallstones, liver metastases or stable chronic liver disease per investigator assessment)
Subjects who have current active hepatic or biliary disease (with exception of patients with Gilbert's syndrome, asymptomatic gallstones, hepatic involvement by MCL, or stable chronic liver disease per investigator assessment)
Non-amyloidosis related chronic liver disease (with the exception of Gilbert's syndrome or clinically asymptomatic gallstones)
Chronic liver disease or current active liver or biliary disease not attributable to amyloidosis (with the exception of Gilbert's syndrome or asymptomatic gallstones). Exclusion criteria for Group 3
Chronic liver disease or current active liver or biliary disease not attributable to amyloidosis (with the exception of Gilbert's syndrome or asymptomatic gallstones).
Patients who have current active hepatic or biliary disease (with the exception of patients with Gilbert's syndrome, asymptomatic gallstones, liver involvement by CLL, or stable chronic liver disease per investigator assessment) are NOT eligible
Current unstable liver or biliary disease per investigator assessment defined by the presence of ascites, encephalopathy, coagulopathy, hypoalbuminemia, esophageal or gastric varices, persistent jaundice, or cirrhosis. Stable chronic liver disease (including Gilbert's syndrome or asymptomatic gallstones) or hepatobiliary involvement of malignancy is acceptable if subject otherwise meets entry criteria.
Current active liver or biliary disease (with the exception of Gilbert's syndrome or asymptomatic gallstones, or otherwise stable chronic liver disease per investigator's assessment).
Current active liver or biliary disease (with the exception of Gilbert's syndrome or asymptomatic gallstones, liver metastases or otherwise stable chronic liver disease per investigator assessment).
Patients with active hepatic or biliary disease (with exception of patients with Gilbert’s syndrome, asymptomatic gallstones, liver metastases or stable chronic liver disease per investigator assessment)
Subjects who have current active hepatic or biliary disease (with exception of patients with Gilbert's syndrome, asymptomatic gallstones, liver metastases or stable chronic liver disease per investigator assessment)
Patients with current active hepatic or biliary disease (with exception of patients with Gilbert's syndrome, asymptomatic gallstones, liver metastases or stable chronic liver disease per investigator assessment)
Significant gastrointestinal disorder with diarrhea as a major symptom (example Crohn's disease, ulcerative colitis) or grade >= 2 diarrhea of any etiology at baseline; active hepatobiliary disease with the exception of patients with Gilbert's syndrome, asymptomatic gallstones, liver metastases, or stable chronic liver disease as determined by investigator's assessment
Patients who have current active hepatic or biliary disease (with exception of patients with Gilbert's syndrome, asymptomatic gallstones, or stable chronic liver disease per investigator assessment);
Current active liver or biliary disease.
Current active hepatic or biliary disease (with exception of subjects with Gilbert's syndrome, asymptomatic gallstones, liver metastases, or stable chronic liver disease per investigator assessment)
Subjects who have current active hepatic or biliary disease (with exception of participants with Gilbert's syndrome, asymptomatic gallstones, liver metastases or stable chronic liver disease per investigator assessment)
Current active hepatic or biliary disease such as cirrhosis, chronic active hepatitis, or chronic persistent hepatitis (with exception of patients with Gilbert's syndrome and asymptomatic gallstones)
Subjects who have current active hepatic or biliary disease (with the exception of patients with Gilbert's syndrome, asymptomatic gallstones, liver metastases or stable chronic liver disease per investigator assessment)
Current active hepatic or biliary disease (with exception of liver disease secondary to chronic GVHD, or patients with Gilbert's syndrome, asymptomatic gallstones, or stable chronic liver disease per investigator assessment)\r\n* Patients with abnormal liver function tests (bilirubin, alkaline phosphatase, alanine aminotransferase [ALT], aspartate aminotransferase [AST]) due to chronic GVHD are specifically not excluded from the study; this is a common manifestation of chronic GVHD, and thus a major target for the study therapy
Current active hepatic or biliary disease (with exception of patients with Gilbert's syndrome, asymptomatic gallstones, liver metastases or stable chronic liver disease per investigator assessment)
Subjects who have current active hepatic or biliary disease (with exception of patients with Gilbert's syndrome, asymptomatic gallstones, liver metastases or stable chronic liver disease per investigator assessment) are ineligible
Subjects who have current active hepatic or biliary disease (with exception of patients with Gilbert's syndrome, asymptomatic gallstones, liver metastases or stable chronic liver disease per investigator assessment)
Subjects who have current active hepatic or biliary disease (with exception of patients with Gilbert's syndrome, asymptomatic gallstones, liver metastases or stable chronic liver disease per investigator assessment)
Current active hepatic or biliary disease (with the exception of patients with Gilbert's syndrome, asymptomatic gallstones, liver metastases, or stable chronic liver disease per investigator assessment)
Active infection (febrile and requiring IV/oral [PO] antibiotics), including hepatitis C or human immunodeficiency virus (HIV), or significant medical illness including renal, cardiac, pulmonary disease, or current active hepatic or biliary disease (with exception of patients with Gilbert's syndrome, asymptomatic gallstones, liver metastases or stable chronic liver disease per investigator assessment)
Current active liver or biliary disease (except Gibler's syndrome or asymptomatic gallstones, liver metastases, or otherwise stable chronic liver disease)
Subjects who have current active hepatic or biliary disease (with exception of patients with Gilbert's syndrome, asymptomatic gallstones, liver involvement with NHL or stable chronic liver disease per treating investigator assessment)
Subjects who have current active hepatic or biliary disease (with exception of patients with Gilbert's syndrome, asymptomatic gallstones, liver metastases or stable chronic liver disease per investigator assessment)
Acute or current active (requiring anti-viral therapy) hepatic or biliary disease (with the exception of subjects with Gilbert's syndrome, asymptomatic gallstones, liver metastases or stable chronic liver disease per investigator assessment)
Current active liver or biliary disease (with the exception of Gilbert's syndrome or asymptomatic gallstones, liver metastases or otherwise stable chronic liver disease per investigator's assessment).
Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) =< 3 x upper limit of normal (ULN) (with exception of patients with Gilbert's syndrome, asymptomatic gallstones, liver involvement with non-Hodgkin lymphoma [NHL] or stable chronic liver disease per investigator assessment)
Total bilirubin =< 1.5 x ULN (with exception of patients with Gilbert's syndrome, asymptomatic gallstones, liver involvement with NHL or stable chronic liver disease per investigator assessment)
Subjects who have currently active hepatic or biliary disease (with exception of patients with Gilbert's syndrome, asymptomatic gallstones, liver involvement with NHL or stable chronic liver disease per investigator assessment)
Current active liver or biliary disease (with the exception of Gilbert's syndrome or asymptomatic gallstones, or liver metastases).
Patients must not have current active hepatic or biliary disease (with exception of patients with Gilbert’s syndrome, asymptomatic gallstones, or stable chronic liver disease per investigator assessment)
Current active liver or biliary disease. Exception: Subjects with Gilbert's syndrome or asymptomatic gallstones, liver metastases related to indolent NHL or otherwise stable chronic liver disease per investigator assessment, are eligible.
Current active liver or biliary disease (with the exception of Gilbert's syndrome or asymptomatic gallstones).
have acute or currently active/requiring anti-viral therapy hepatic or biliary disease (with exception of patients with Gilbert's syndrome, asymptomatic gallstones, liver metastases or stable chronic liver disease);
Have current active hepatic or biliary disease (with exception of subjects with Gilbert's syndrome, asymptomatic gallstones, liver metastases or stable chronic liver disease per investigator assessment).
Current active liver or biliary disease (with the exception of Gilbert's syndrome or asymptomatic gallstones, liver metastases, or otherwise stable chronic liver disease per investigator assessment).
Subjects who have currently active hepatic or biliary disease (with the exception of patients with Gilbert's syndrome)
Patients with current active hepatic or biliary disease (with exception of patients with Gilbert's syndrome, asymptomatic gallstones, liver metastases or stable chronic liver disease)
Current active liver or biliary disease (with the exception of Gilbert's syndrome or asymptomatic gallstones, liver metastases or otherwise stable chronic liver disease per investigator's assessment).
Have acute or currently active/requiring anti-viral therapy hepatic or biliary disease (with the exception of patients with Gilbert's syndrome, asymptomatic gallstones, liver metastases or stable chronic liver disease per investigator assessment)
Total bilirubin =< 1.5 x institutional upper limit of normal (ULN) (except patients with Gilbert syndrome, who can have total bilirubin < 3.0 mg/dL)
Total bilirubin =< 1.5 X institutional upper limit of normal (ULN) (except subjects with Gilbert syndrome, who can have total bilirubin < 3 mg/dL) must be obtained =< 7 days prior to protocol registration
Total bilirubin =< 1.5 x institutional upper limit of normal (IULN) (except Gilbert's syndrome, who must have a total bilirubin < 3.0 mg/dL)
Total bilirubin ? 1.5 mg/dL (upper limit of normal) except subject with documented Gilbert's syndrome (? 5 x ULN) or liver metastasis, who must have a baseline total bilirubin ? 3.0 mg/dL
Bilirubin less than or equal to 1.5 x the upper limit of normal (except subjects with Gilbert syndrome, who can have total bilirubin < 3 mg/dl)
Bilirubin (total) within normal institutional limits (except subjects with Gilbert syndrome who must have total bilirubin < 3.0 mg/dL)
Total bilirubin =< 1.5 x the upper limits of normal (ULN), except for subjects with Gilbert Syndrome who can have bilirubin < 3
Total bilirubin should be =< 2 x upper limit of normal (ULN) (patients with Gilbert's syndrome must have a total bilirubin less than 3.0 mg/dL)
Bilirubin ?1.5x the upper limit of normal (ULN). For subjects with documented Gilbert's disease, bilirubin ?3.0 mg/dL. For subjects with documented liver metastases, bilirubin ? 2.5x ULN.
Obtained within 28 days prior to registration: Bilirubin =< 1.5 x upper limit of normal (ULN) (except subjects with Gilbert syndrome, who can have total bilirubin < 3.0 mg/dL)
Total bilirubin within 1.5 x the upper limit of normal institutional limits; patients with elevation of unconjugated bilirubin alone, as in Gilbert's disease, are eligible, performed within 14 days prior to day 1 of protocol therapy
Total bilirubin < 1.5 x institutional normal limits (subjects with known Gilbert syndrome are eligible with total bilirubin < 3.0 mg/dL).
Total bilirubin =< 1.5 x normal institutional limits; for patients (Pts) with liver metastasis: total bilirubin must be within normal limits; (except patients with Gilbert syndrome, who can have total bilirubin < 3.0 mg/dL)
Bilirubin less than or equal to 1.5 x the upper limit of normal (except subjects with Gilbert syndrome, who can have total bilirubin < 3 mg/dl)
Total bilirubin =< 1.5 x ULN (upper limit of normal) except subject with documented Gilbert's syndrome (=< 5 x ULN) or liver metastasis, who must have a baseline total bilirubin =< 3.0 mg/dL
Bilirubin less than or equal to 1.5 x the upper limit of normal (except subjects with Gilbert syndrome, who can have total bilirubin < 3 mg/dl)
Total bilirubin =< 1.5 x institutional upper limit of normal (ULN) except for patients with bilirubin elevation due to Gilbert's disease or of non-hepatic origin who will be allowed to participate, provided bilirubin is =< 3 x institutional ULN.
Total bilirubin =< 1.5 x upper limit of normal (ULN) (except subjects with Gilbert syndrome who can have total bilirubin < 3.0 mg/dL)
Patients must have adequate organ and bone marrow function within 14 days prior to registration, as defined by: total bilirubin total bilirubin =< 1.5 x institutional upper limit of normal (ULN) (except patients with Gilbert syndrome or liver metastasis, who can have total bilirubin =< 3.0 x ULN)
Total bilirubin =< 1.5 x institutional upper limit of normal (ULN), except patients with Gilbert's syndrome in whom total bilirubin must be < 3.0 mg/dL, within 2 weeks of registration (except where specified otherwise)
Total bilirubin =< 1.5 x upper limit of normal (ULN) (except patients with Gilbert Syndrome, who can have total bilirubin < 3.0 mg/dL)
FULL STUDY INCLUSION CRITERIA: Total bilirubin =< 1.5 x the upper limit of normal (ULN); documented Gilbert syndrome is allowed if total bilirubin is mildly elevated (< 6 mg/dL)
Total bilirubin with 1.5 x the upper limit of normal (ULN) institutional limits; patients with elevation of unconjugated bilirubin alone, as in Gilbert's disease, are eligible
To be performed within 10 business days prior to day 1: Total bilirubin within 1.5 x the upper limit of normal institutional limits; patients with elevation of unconjugated bilirubin alone, as in Gilbert's disease, are eligible
Total bilirubin =< 1.5 x institutional upper limit of normal (ULN) (except patients with Gilbert syndrome, who can have total bilirubin < 3.0 mg/dL), within 14 days prior to treatment
EXCEPTIONS:\r\n* Total bilirubin >= 5 mg/dL in patients with Gilbert's syndrome as defined by > 80% unconjugated\r\n* Total bilirubin >= 7.5 with direct fraction > 0.7 if patient is receiving a protease inhibitor at the time of initial evaluation\r\n* Hepatic dysfunction attributed to lymphoma, KSHV-MCD, or KICS
Total bilirubin =< 1.5 times the institutional upper limit of normal (ULN) (except subjects with Gilbert syndrome, who can have total bilirubin < 3.0 mg/dL)
Total bilirubin < 1.5 X institutional normal limits (subjects with known Gilbert syndrome are eligible with total bilirubin < 3.0 mg/dL)
Total bilirubin within 1.5 x the upper limit of normal institutional limits; patients with elevation of unconjugated bilirubin alone, as in Gilbert's disease, are eligible
Total bilirubin =< 1.5 x institutional upper limit of normal (ULN) (except patients with Gilbert syndrome, who can have total bilirubin < 3.0 mg/dL)
Total serum bilirubin =< 1.5 x upper limit of normal (ULN) (except subjects with Gilbert syndrome, who can have total bilirubin < 3.0 mg/dL)
Total bilirubin =< 1.5 X normal institutional limits (except subjects with Gilbert syndrome, who can have total bilirubin < 3.0 mg/dL)
Within 14 days prior to study entry: Bilirubin =< 1.5 x upper limit of normal (ULN); except subjects with Gilbert syndrome, who can have total bilirubin < 3.0 mg/dL
Serum bilirubin within (or under) normal limits (OR total bilirubin =< 3.0 x institutional upper limit of normal [IULN] with direct bilirubin within normal range in patients with well documented Gilbert syndrome)
Total bilirubin within normal institutional limits (patients with Gilbert's syndrome must have a total bilirubin < 3.0 mg/dL)
Total bilirubin ? 1.5 x upper limit of normal (ULN) (except patients with Gilbert Syndrome, who can have total bilirubin < 3.0 mg/dL)
Serum total bilirubin =< 1.5 x institutional upper limit of normal (ULN) (patients with Gilbert's syndrome with a total bilirubin < 3.0 mg/dL)
Total bilirubin\r\n* If no known liver metastases:\r\n** Total bilirubin =< 1.5 x institutional upper limit of normal (ULN) (except subjects with Gilbert syndrome, who may have total bilirubin < 3.0 mg/dl)\r\n* If known metastasis:\r\n** Total bilirubin =< 5 ULN
Bilirubin less than or equal to 1.5 x the upper limit of normal (except subjects with Gilbert syndrome, who can have total bilirubin < 3 mg/dl)
Total bilirubin within normal institutional limits; EXCEPTION: subjects with known Gilbert's disease: total bilirubin =< 3 x institutional upper limit of normal (ULN)
Total bilirubin =< 1.5 x institutional upper limit of normal (ULN) (except patients with Gilbert syndrome, who can have total bilirubin < 3.0 mg/dL)
Total bilirubin ? 1.5 upper limit of normal (ULN), except for participants with Gilbert's syndrome as defined by > 80% unconjugated bilirubin and total bilirubin ? 6 mg/dL
Total bilirubin within normal institutional limits, patients with elevation of unconjugated bilirubin alone, as in Gilbert's disease, are eligible
Total bilirubin =< 1.5 x institutional upper limit of normal (ULN) except for patients with bilirubin elevation due to Gilbert's disease who will be allowed to participate
Total bilirubin =< 1.5 x institutional upper limit of normal (ULN) (except patients with Gilbert syndrome, who can have total bilirubin < 3.0 mg/dL)
Total bilirubin =< 1.5 x institutional upper limit of normal (ULN) (except patients with Gilbert syndrome, who can have total bilirubin < 3.0 mg/dL)
Total bilirubin =< 1.5 X institutional upper limit of normal\r\n* Note: patients with hyperbilirubinemia clinically consistent with an inherited disorder of bilirubin metabolism (e.g., Gilbert syndrome) will be eligible at the discretion of the treating physician and/or the principal investigator
Total bilirubin levels ? 1.5 x upper limit of normal [ULN] (except for patients with Gilbert's Syndrome, who must have a total bilirubin of less than 3.0 mg/dL)
Total bilirubin =< upper limit of normal (ULN) except subjects with Gilbert syndrome, who can have total bilirubin < 3.0 mg/dL
Serum bilirubin =< 1.5 times the upper institutional limits of normal (ULN); patients with a history of Gilbert's syndrome may be enrolled if the total bilirubin is < 3 mg/dL with a predominance of indirect bilirubin
Total bilirubin =< 2.5 x upper limit of normal (ULN) unless due to Gilbert's disease; for those with a total bilirubin > 2.5 x ULN, a direct bilirubin should be performed and must be < 1.5 mg/dL for Gilbert's to be diagnosed; if value is higher due to hepatic involvement by CLL, patient is eligible
Total bilirubin within normal institutional limits; for patients with Gilbert's syndrome, total bilirubin =< 3.0 mg/dL
Total bilirubin =< 1.2 mg/dL; for patients with Gilbert syndrome, the direct bilirubin should be within the institutional normal range
Total bilirubin =< 1.5 x institutional limits unless documented Gilbert's syndrome (then < 2.5 x institutional upper limit)
Bilirubin < 1.5x ULN (except for patients with Gilbert's disease, for whom the upper acceptable limit of serum bilirubin is 3mg/dL)
Total bilirubin =< 1.5 x the upper limit of normal (ULN); for subjects with known Gilbert's disease, bilirubin =< 3.0 mg/dL
Total bilirubin =< 1.5 x institutional upper limit of normal; Note: patients with hyperbilirubinemia clinically consistent with an inherited disorder of bilirubin metabolism (e.g., Gilbert syndrome) will be eligible at the discretion of the treating physician and/or the principal investigator
Total bilirubin ? 1.5 x the upper limit of normal (ULN). Mildly elevated total bilirubin (< 6 mg/dL) is allowed if Gilbert's syndrome is documented.
Total bilirubin =< 1.5 x institutional upper limit of normal; note: patients with hyperbilirubinemia clinically consistent with an inherited disorder of bilirubin metabolism (e.g., Gilbert syndrome) will be eligible at the discretion of the treating physician and/or the principal investigator
Bilirubin =< 1.5 x the upper limit of normal (ULN); for subjects with known Gilbert's disease, bilirubin =< 3.0 mg/dL
Total bilirubin within 1.5 x of the upper limit of normal (ULN) institutional limits, patients with elevation of unconjugated bilirubin alone, as in Gilbert's disease, are eligible
Serum bilirubin ? 1.5 times the upper limits of normal. Subjects with a history of Gilbert's syndrome may be enrolled if the total bilirubin is < 3 mg/dL with an indirect bilirubin of > 1.5 mg/dL
Bilirubin =< 1.5 mg/dL (or =< 3.0 mg/dL if due to Gilbert's syndrome) within 28 days prior to registration
Bilirubin =< 1.5 mg/dL (or =< 3.0 mg/dL if due to Gilbert's syndrome or if liver metastases are present)
Total bilirubin of ? 2.0 mg/dL (? 3.0 mg/dL for patients with known Gilbert's syndrome)
Bilirubin >1.5 mg/dL, except for Gilbert's Syndrome or hemolysis.
Total bilirubin <2.0 mg/dL unless elevated due to known Gilbert's syndrome.
Total bilirubin < 2.0 mg/dl (unless attributable to Gilbert's disease)
Total bilirubin ?1.5 mg/dL unless elevated due to known Gilbert's syndrome.
Have a total bilirubin level ?2.0 mg/dL (unless secondary to Gilbert syndrome, hemolysis, or leukemia)
Total bilirubin ?1.5 mg/dL not related to hemolysis or Gilbert's disease
Total bilirubin (TBL) ? 2.5 mg/dL, except for participants with Gilbert's syndrome.
TBL < 2.5 mg/dL, except for participants with Gilbert's syndrome.
A bilirubin of less than or equal to 1.5 mg/dL, excluding patients with Gilbert's disease
Direct bilirubin must be < 2 mg/dL unless the elevation is known to be due to Gilbert syndrome within 3 days prior to enrollment.
Total bilirubin < 2.0 mg/dL (? 3.0 mg/dL for patients with known Gilbert's syndrome)
Bilirubin < 2.5 mg/dL (unless due to Gilbert's disease)
Total bilirubin < 1.5 mg/dL (or =< 3.0 mg/dL in patients with Gilbert syndrome)
A bilirubin of up to 2.0 mg/dL, excluding patients with Gilbert's disease
Direct bilirubin must be < 2 mg/dL unless the elevation is known to be due to Gilbert's syndrome or acute GVHD (aGVHD) within 3 days of enrollment
Patients with Gilbert syndrome are excluded from the requirement of a normal bilirubin but they must have an indirect bilirubin of < 6 mg/dl, and a direct bilirubin of < 0.5 mg/dl in order to be eligible; (Gilbert syndrome is found in 3-10% of the general population and is characterized by mild, chronic hyperbilirubinemia in the absence of liver disease or overt hemolysis)
Bilirubin (Gilbert's Disease) =< 3.0 mg/dL
Bilirubin =< 1.5 mg/dl (unless Gilbert's syndrome)
Patients must have a bilirubin level of < 2.0 mg/dl in the absence of a history of Gilbert's disease (or pattern consistent with Gilbert's)
Have a total bilirubin level ?2.0 mg/dL (unless secondary to Gilbert syndrome, hemolysis, or leukemia)
Total bilirubin >= 2.0 mg/dl in the absence of a history of Gilbert's disease
Bilirubin =< 2.0 mg/dl, unless known Gilbert's syndrome
Serum total bilirubin < 2 mg/dl (except if known Gilbert syndrome AND normal transaminases)
Total bilirubin ? 2.0 mg/dL not related to hemolysis or Gilbert's disease.
Total bilirubin =< 2 mg/dL (=< 3 mg/dL in case of Gilbert's syndrome)
Bilirubin < 1.5 mg/dL, with the exception of patients thought to have Gilbert's syndrome, who may have a total bilirubin above 1.5 mg/dL
Total bilirubin =< 1.5 mg/dL (25.65 umol/L) (except patients with Gilbert's disease)
Serum bilirubin > 2.0 mg/dl (except in the case of Gilbert syndrome or ongoing hemolytic anemia)
Total bilirubin ? 2.0 mg/dL not related to Gilbert's disease or hemolysis.
Patients must have adequate organ and marrow function defined as: absolute neutrophil count (ANC) >/= 1,000/mL, platelets >/=75,000/mL; creatinine clearance >/= 35 ml/min; total bilirubin </= 2 X ULN (exceptions may apply to benign non-malignant indirect hyperbilirubinemia such as Gilbert syndrome); ALT (SGPT) and or AST (SGOT) </= 5 X ULN Exception for patients with liver metastasis: total bilirubin </= 3 x ULN; ALT (SGPT) </= 8 X ULN; Fasting lipid profile: cholesterol </= 350 mg/dL; triglycerides </= 400 mg/dL Corrected calcium >/= 8.4 mg/dL; phosphorus >/= 2.5 mg/dL for denosumab
Bilirubin =< 1.5 mg/dl (unless Gilbert's syndrome)
Bilirubin =< 1.5 mg/dL (or =< 3.0 mg/dL if due to Gilbert's syndrome)
Alanine aminotransferase ? 5 × ULN and total bilirubin < 2.0 mg/dL (or < 3.0 mg/dL for subjects with Gilbert's syndrome or leukemic infiltration of the liver)
Total bilirubin > 2.0 mg/dL (or > 3.0 mg/dL in participants with documented Gilbert syndrome)
Serum total bilirubin < 2.0 mg/dL, patients with Gilbert's Syndrome should contact the medical monitor
Total serum bilirubin must be < 3 mg/dL unless the elevation is thought to be due to Gilbert's disease or hemolysis
Serum bilirubin < 2 mg/dL (unless due to Gilbert's syndrome)
Bilirubin < 2.0 mg/dl (unless attributed to Gilbert's disease)
Total bilirubin =< 1.5 mg/dl unless felt secondary to Gilbert's disease
Serum direct bilirubin < 1.5 mg/dL (unless Gilbert's syndrome)
Serum direct bilirubin < 1.5 mg/dL (unless Gilbert's syndrome)
Hepatic: Bilirubin ? 2.5 mg/dL (except in the case of Gilbert's syndrome or ongoing hemolytic anemia); and ALT, AST and Alkaline Phosphatase ? 5 × ULN.
total bilirubin of ? 2.0 mg/dl (? 3.0 mg/dl for patients with known Gilbert's syndrome)
Patient must have adequate hepatic function documented by a total bilirubin of ? 2.0 mg/dl (? 3.0 mg/dl for patients with known Gilbert's syndrome) and ALT and AST ? 3 times the ULN for the reference lab.
Total bilirubin =< 1.5 mg/dL (unless there is a known history of Gilbert's syndrome)
Bilirubin =< 1.5 mg/dl (unless Gilbert's syndrome)
Patients must have a serum bilirubin equal to or =< 2.0 mg/dl (isolated hyperbilirubinemia related to Gilbert's disease allowed)
Serum direct bilirubin >= 1 mg/dl (except Gilbert's syndrome or hemolysis)
At the discretion of the operating surgeon, bilirubin level of < 2.0 mg/dl in the absence of a history of Gilbert's disease (or pattern consistent with Gilbert’s)
At the discretion of the physician, bilirubin level of < 2.0 mg/dl in the absence of a history of Gilbert's disease (or pattern consistent with Gilbert's)
Total serum bilirubin ? ULN; or total bilirubin ? 3.0 × ULN with direct bilirubin within normal range in patients with documented Gilbert's Syndrome.
Total bilirubin ? 1.5 × ULN (except in patients with Gilbert Syndrome who can have total bilirubin < 3.0 mg/dL). Direct bilirubin ? ULN for patients with total bilirubin levels >1.5 × ULN.
Serum bilirubin ? institutional 1.5 times upper limit of normal (ULN) (OR for patients with documented Gilbert syndrome, total bilirubin ? 3.0 times ULN with direct bilirubin ? ULN)
total bilirubin ? 1.5 × upper limit of normal (ULN) OR direct bilirubin ? ULN for subjects with total bilirubin levels > 1.5 x ULN (except subject with Gilbert's Syndrome, who can have total bilirubin < 3.0 mg/dl)
Total serum bilirubin ?1.5 x ULN. In subjects with Gilbert's syndrome, if total bilirubin is >1.5 × ULN, measure direct and indirect bilirubin and if direct bilirubin is ?1.5 × ULN, subject may be eligible)
Total serum bilirubin ? 1.5 × upper limit of normal for the study site (ULN) (in patients with known Gilbert Syndrome, total bilirubin ? 3 × ULN, with direct bilirubin ? 1.5 × ULN)
Total bilirubin ?1.5 times the upper limit of normal (ULN) (in patients with known Gilbert Syndrome, a total bilirubin ?3.0 x ULN, with direct bilirubin ?1.5 x ULN)
Total serum bilirubin ? 1.5 x ULN (in subjects with known Gilbert Syndrome, a total bilirubin ? 3.0 x ULN, with direct bilirubin ? 1.5 x ULN)
Total bilirubin ? 2x the institutional ULN with the exception of patients with Gilbert syndrome; patients with Gilbert syndrome may be included if their total bilirubin is ? 3.0x ULN and direct bilirubin is ? 2x ULN
Total bilirubin =< institutional upper limit of normal (ULN) (except in patients with Gilbert's syndrome; patients with Gilbert's syndrome may enroll if direct bilirubin is =< 1.5 x ULN
Total bilirubin level ? 1.5 x ULN, except for patients with known Gilbert's syndrome (confirmed by the UGT1A1 polymorphism analysis), who are excluded if total bilirubin>3.0 x ULN or direct bilirubin > 1.5 x ULN
Total bilirubin >1.5 times ULN, except for patients with Gilbert's syndrome who are excluded if total bilirubin >3.0 x ULN or direct bilirubin >1.5 x ULN
Total serum bilirubin < ULN; or total bilirubin ? 3.0 × ULN with direct bilirubin within normal range in patients with well-documented Gilbert's Syndrome
Bilirubin > 1.5 x upper limit of normal (ULN), except for patients with known Gilbert syndrome who are excluded if total bilirubin > 3.0 x ULN or direct bilirubin > 1.5 x ULN
Total bilirubin < 2.0 mg/dl with the exception of patients with Gilbert syndrome; patients with Gilbert syndrome may be included if their total bilirubin is >= 3.0 x upper limit of normal (ULN) and direct bilirubin =< 1.5 x ULN
Total bilirubin > 1.5 x ULN, except for patients with Gilbert's syndrome who are excluded if total bilirubin > 3.0 x ULN or direct bilirubin > 1.5 x ULN.
Total serum bilirubin =< 1.5 x ULN (in patients with known Gilbert syndrome, a total bilirubin =< 3.0 x ULN, with direct bilirubin =< 1.5 x ULN)
Total bilirubin < 2.5 x upper limit of normal (ULN); direct bilirubin < 2 x ULN for Gilbert's syndrome;
Serum total bilirubin within normal range (or =< 1.5 x upper limit of normal [ULN] if liver metastases are present; or total bilirubin =< 3.0 x ULN with direct bilirubin within normal range in patients with well documented Gilbert syndrome), obtained =< 14 days prior to registration
Serum bilirubin within normal range (or =< 1.5 x upper limit normal [ULN] if liver metastases are present; or total bilirubin =< 3.0 x ULN with direct bilirubin within normal range in patients with well documented Gilbert syndrome)
Total serum bilirubin >2.5 × upper limit of normal (ULN; except for subjects with Gilbert's Syndrome for whom direct bilirubin is <2.5 × ULN), or liver cirrhosis, or chronic liver disease Child-Pugh Class B or C.
Total bilirubin > 1.5 x ULN, except for patients with Gilbert's syndrome who are excluded if total bilirubin > 3.0 x ULN or direct bilirubin > 1.5 x ULN
Total bilirubin ?1.5 x the upper limit of the normal range (ULN) (except for Gilbert syndrome: direct bilirubin ?2 x ULN).
Total bilirubin > 2 mg/dL, except for patients with Gilbert's syndrome who are excluded if total bilirubin > 3.0 x ULN or direct bilirubin > 1.5 x ULN
Serum bilirubin within normal range (or =< 1.5 x ULN if liver metastases are present; or total bilirubin =< 3.0 x ULN with direct bilirubin within normal range in patients with well documented Gilbert Syndrome)
At cycle 1 day 1 pre-dosing: Total bilirubin level >= 1.5 x ULN, (except for Gilbert syndrome: direct bilirubin >= 1.5 x ULN)
Total bilirubin > 1.5 × ULN; > 3 × ULN with direct bilirubin > 1.5 × ULN in presence of Gilbert's disease.
Total serum bilirubin >2.5 ULN (except for subjects with Gilbert's Syndrome for whom direct bilirubin is <2.5×ULN), or liver cirrhosis or chronic liver disease Child-Pugh Class B or C.
Total serum bilirubin =< 1.5 x ULN (in patients with known Gilbert syndrome, a total bilirubin =< 3.0 x ULN, with direct bilirubin =< 1.5 x ULN)
Bilirubin < 1.5 x upper limit of normal (ULN), for patients with Gilbert syndrome, direct bilirubin will be measured instead of total bilirubin
Serum bilirubin < 2 x ULN for patients with liver metastases and =< 1.5 x ULN for patients without liver metastases, (except patients with Gilbert's syndrome, who must have a total bilirubin < 3.0 mg/dL)
Serum bilirubin =< 1.5 x ULN in patients with known Gilbert syndrome, total bilirubin =< 3 x ULN, with direct bilirubin =< 1.5 x ULN
Bilirubin ? 2.0 mg/dl with the exception of patients with Gilbert-Meulengracht syndrome; patients with Gilbert-Meulengracht syndrome may be included if their total bilirubin is ? 3.0 x ULN and direct bilirubin ? 1.5 x ULN
Total bilirubin =< 1.0 X ULN (institutional); for patients with Gilbert syndrome, the direct bilirubin should be within the institutional normal range
Total bilirubin <upper limit of normal (ULN) except in participants with Gilbert's syndrome. Participants with Gilbert's syndrome may enroll if direct bilirubin <=1.5*ULN of the direct bilirubin.
Serum bilirubin WNL or ?1.5 x the ULN in patients with liver metastases; or total bilirubin ?3.0 x ULN with direct bilirubin WNL in patients with well documented Gilbert's Syndrome.
Total bilirubin > 1.5 x ULN, except for patients with Gilbert's syndrome who are excluded if total bilirubin > 3.0 x ULN or direct bilirubin > 1.5 x ULN
Within 14 days prior to registration: total bilirubin =< 1.5 x institutional ULN (except participants with Gilbert syndrome, who can have total bilirubin =< 3.0 x institutional ULN with direct bilirubin that is within institutional ULN)
Serum bilirubin =< upper limit of normal; or total bilirubin =< 2.0 x the ULN with direct bilirubin within the normal range in patients with well documented Gilbert syndrome
Serum bilirubin within normal range (or =< 1.5 x ULN if liver metastases are present; or total bilirubin =< 3.0 x ULN with direct bilirubin within normal range in patients with well documented Gilbert syndrome)
Total bilirubin =< upper limit of normal (ULN) except in patients with Gilbert's syndrome; patients with Gilbert's syndrome may enroll if direct bilirubin =< 1.5 x ULN of the direct bilirubin
Serum bilirubin within normal range (or =< 1.8 x ULN if liver metastases are present; or total bilirubin =< 3.0 x ULN with direct bilirubin within normal range in patients with well documented Gilbert syndrome)
Obtained within 2 weeks from study entry: Total bilirubin =< 1.5 x upper limit of normal (ULN) (patients with known Gilbert syndrome, a total bilirubin =< 3.0 x ULN, with direct bilirubin =< 1.5 x ULN)
Direct bilirubin ? 1.5 x ULN except for i) patient with documented Gilbert's syndrome for whom any bilirubin value is allowed and ii) for patients with asymptomatic hyperbilirubinemia (liver transaminases and alkaline phosphatase within normal range)
ARMs A, C, D: Total bilirubin within normal range (or =< 1.5 X upper limit of normal [ULN] if liver metastases are present); or total bilirubin =< 3.0 x ULN with direct bilirubin within normal range in patients with Gilbert syndrome
ARM B: Total bilirubin =< 1.5 X ULN (in patients with known Gilbert syndrome a total bilirubin =< 3.0 x ULN with direct bilirubin =< 1.5 X ULN)
Total bilirubin =< 1.5 x upper limit of normal (ULN); in patients with known Gilbert's syndrome direct bilirubin =< 1.5 x ULN will be used as organ function criteria, instead of total bilirubin
Total serum bilirubin =< 1.5 x ULN (=< 3 x ULN with direct bilirubin within normal range in patients with documented hepatic involvement, well documented Gilbert's syndrome)
Total bilirubin ? 1.5× ULN (or ? 3× ULN, with direct bilirubin ?1.5 × ULN, in patients with known Gilbert syndrome).
Serum bilirubin within normal range (or =< 1.5 x ULN if liver metastases are present; or total bilirubin =< 3.0 x ULN with direct bilirubin within normal range in patients with well-documented Gilbert Syndrome)
Serum total bilirubin =< 1.5 x ULN OR total bilirubin =< 4.0 ULN with direct bilirubin =< 1.5 x ULN in patients with well documented Gilbert syndrome
Bilirubin =< 1.5 x upper limit of normal (ULN) (CTCAE v4.03 grade 1; in patients with known Gilbert syndrome, a total bilirubin =< 3.0 x ULN, with direct bilirubin =< 1.5 x ULN)
Serum bilirubin within normal range (or total bilirubin =< 3.0 x upper limit of normal [ULN] with direct bilirubin within normal range in patients with well documented Gilbert syndrome)
Total bilirubin ? 1.5 × ULN except in patients with Gilbert's syndrome. Patients with Gilbert's syndrome may enroll if direct bilirubin ? 1.5 × ULN of the direct bilirubin.
Adequate hepatic function as evidenced by the following serum chemistry values: total bilirubin, ULN. If total bilirubin is greater than (>) ULN, measure indirect bilirubin to evaluate for Gilbert's syndrome (if direct bilirubin is within normal range, participant may be eligible) ALP 2.5 x ULN; Trabectedin: if the ALP is >2.5 x ULN, then an ALP liver fraction or 5-nucleotidase must be obtained and ULN, AST and ALT 2.5 ULN
Bilirubin > 1.5 x upper limit normal (ULN), except for patients with known Gilbert syndrome who are excluded if total bilirubin > 3.0 x ULN or direct bilirubin > 1.5 x ULN
Serum total bilirubin =< ULN or 1.5 x ULN if liver metastases are present or total 3 x ULN with direct bilirubin =< ULN in patients with well documented Gilbert syndrome
Total bilirubin >1.5 × ULN; >3 × ULN with direct bilirubin, >1.5 × ULN in the presence of Gilbert's Disease
Direct bilirubin ? 1.5 x ULN except for i) patients with documented Gilbert's syndrome for whom any bilirubin value is allowed and ii) for patients with asymptomatic hyperbilirubinemia (liver transaminases and alkaline phosphatase within normal range).